Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
LL Bioboost Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
CJC-1295 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Class II · Moderate risk
Theophylline
OOS results reported for the Dissolution (by UV) test.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Celecoxib Capsules
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Celecoxib Capsules
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations